EP1589954B1 - Composition comprenant un melange de principes actifs, et procede pour la preparer - Google Patents

Composition comprenant un melange de principes actifs, et procede pour la preparer Download PDF

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Publication number
EP1589954B1
EP1589954B1 EP04703798.1A EP04703798A EP1589954B1 EP 1589954 B1 EP1589954 B1 EP 1589954B1 EP 04703798 A EP04703798 A EP 04703798A EP 1589954 B1 EP1589954 B1 EP 1589954B1
Authority
EP
European Patent Office
Prior art keywords
active principle
weight
coating
core
binding agent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP04703798.1A
Other languages
German (de)
English (en)
Other versions
EP1589954A2 (fr
Inventor
Philippe Chenevier
Dominique Marechal
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethypharm SAS
Original Assignee
Ethypharm SAS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ethypharm SAS filed Critical Ethypharm SAS
Publication of EP1589954A2 publication Critical patent/EP1589954A2/fr
Application granted granted Critical
Publication of EP1589954B1 publication Critical patent/EP1589954B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/003—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic followed by coating of the granules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
    • Y10T428/2991—Coated
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
    • Y10T428/2991—Coated
    • Y10T428/2998—Coated including synthetic resin or polymer

Definitions

  • the addition of the diluent to the particle formulation leads to an increase in the unit size and weight of the pharmaceutical form to be administered to the patient, which creates an additional obstacle to be overcome in formulating the medicinal product, and makes it more difficult to administer to patients who have difficulty in swallowing.
  • the core contains from 60 to 99% by weight of the first active principle, advantageously from 80 to 99% by weight, while the coating contains from 60 to 99% by weight of the second active principle, advantageously from 80 to 95% by weight, the rest up to 100% of the core and of the coating consisting of at least one binding agent and optionally an antistatic agent;_wherein the binding agent is chosen from cellulosic polymers, acrylic polymers, povidones, copovidones, polyvinyl alcohols, alginic acid, sodium alginate, starch, pregelatinized starch, sucroses and derivatives thereof, guar gum and polyethylene glycols, alone or as a mixture.
  • the binding agent is chosen from cellulosic polymers, acrylic polymers, povidones, copovidones, polyvinyl alcohols, alginic acid, sodium alginate, starch, pregelatinized starch, sucroses and derivatives thereof, guar gum and polyethylene glycols, alone or as a mixture.
  • the additional functional layer also optionally comprises a plasticizer, a surfactant, an antistatic agent, a lubricant.
  • the plasticizer is used in a proportion of at most 40%, preferably between 15 and 30%, expressed by weight relative to the dry weight of polymer, and chosen from the group comprising triethyl citrate, acetyltributyl citrate, triacetine, tributyl citrate, diethyl phthalate, polyethylene glycols, polysorbates, mono-and diacetylated glycerides, and mixtures thereof.
  • the surfactant is chosen from anionic, cationic, nonionic and amphoteric surfactants.
  • coated particles may be used in any type of formulation intended for oral administration, but are particularly suitable when the pharmaceutical form chosen involves bringing the coated particles into contact with saliva.
  • This type of tablet is, for example, described in documents EP 548356 , EP 636364 , EP 1003484 , EP 1058538 , WO 98/46215 , WO 00/06126 , WO 00/27357 and WO 00/51568 , but the particle of the invention can also be used in any other formulation equivalent to those described in the documents mentioned.
  • a directly compressible polyol and a polyol in the form of a powder are mixed, the polyol in this case being identical or different, the respective proportions of directly compressible polyol and of powdered polyol being from 99/1 to 20/80, preferably from 80/20 to 20/80.
  • flavorings and dyes are those conventionally used in pharmacy for preparing tablets.
  • the particles are prepared according to the following steps:

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Rheumatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • General Preparation And Processing Of Foods (AREA)
  • Cosmetics (AREA)

Claims (18)

  1. Particule enrobée à base de principe actif d'une taille comprise entre 50 µm et 2 mm, dans laquelle à la fois le noyau et l'enrobage contiennent du principe actif, caractérisée en ce que le noyau comprend soit 100% en poids, soit 60-99% en poids d'un premier principe actif tandis que l'enrobage comprend de 60 à 99% en poids d'un second principe actif qui est de nature différente, le complément à 100% de l'enrobage et, le cas échéant du noyau, est constitué d'au moins un agent liant, et éventuellement d'un agent antistatique; dans laquelle l'agent liant est choisi parmi les polymères cellulosiques, les polymères acryliques, les povidones, les co-povidones, les polyvinylalcools, l'acide alginique, l'alginate de sodium, l'amidon, l'amidon prégélatinisé, les sucroses et leurs dérivés, la gomme guar et les polyéthylèneglycols, seuls ou en mélange.
  2. Particule enrobée selon la revendication 1, caractérisée en ce que le noyau contient le principe actif le plus fortement dosé, alors que l'enrobage contient le principe actif le plus faiblement dosé.
  3. Particule enrobée selon la revendication 2, caractérisée en ce que le rapport de dose entre le premier principe actif et le second principe actif est égal ou supérieur à 5, de préférence égal ou supérieur à 10.
  4. Particule enrobée selon la revendication 1, caractérisée en ce que le noyau contient 100 % en poids du premier principe actif, tandis que l'enrobage contient de 80 à 99 % en poids du second principe actif.
  5. Particule enrobée selon la revendication 1, caractérisée en ce que le noyau contient de 60 à 99 % en poids du premier principe actif, tandis que l'enrobage contient de 80 à 95 % en poids du second principe actif.
  6. Particule enrobée selon l'une quelconque des revendications 4 ou 5, caractérisée en ce que le complément à 100 % de l'enrobage et, le cas échéant du noyau, est constitué exclusivement par un agent liant identique ou différent.
  7. Particule enrobée selon la revendication 1, caractérisée en ce que le noyau et/ou l'enrobage contient en outre au moins un agent antistatique dans des proportions allant respectivement jusqu'à 10% en poids, de préférence jusqu'à 3% en poids par rapport au poids du noyau et jusqu'à 10% en poids, de préférence jusqu'à 3% en poids par rapport au poids de l'enrobage.
  8. Particule enrobée selon la revendication 1, caractérisée en ce qu'elle comporte en plus de l'enrobage, une couche fonctionnelle supplémentaire, dont la composition est choisie en fonction des caractéristiques souhaitées de masquage de goût et/ou de libération de principe actif.
  9. Particule selon la revendication 8, caractérisée en ce que la couche fonctionnelle supplémentaire est constituée d'au moins un polymère d'enrobage choisi dans le groupe comprenant les polymères cellulosiques et les polymères acryliques, seuls ou en mélange.
  10. Particule selon la revendication 1, caractérisée en ce qu'elle comprend entre le noyau et l'enrobage, une couche intermédiaire à base d'un polymère choisi dans le groupe comprenant les polymères cellulosiques, les polymères acryliques, les povidones, les co-povidones, les polyvinylalcools, l'acide alginique, l'alginate de sodium, l'amidon, l'amidon prégélatinisé, les sucroses et leurs dérivés, la gomme guar, les polyéthylèneglycols, seuls ou en mélange.
  11. Composition pharmaceutique ou cosmétique comprenant les particules enrobées objet de l'une des revendications 1 à 10.
  12. Composition selon la revendication 11, caractérisée en ce qu'elle se présente sous forme de comprimés, en particulier comprimés multiparticulaires orodispersibles ou dispersibles.
  13. Composition selon la revendication 11, caractérisée en ce qu'elle est une composition pharmaceutique sous forme de sachets.
  14. Procédé de fabrication d'une particule enrobée de principe actif, dont le noyau contient un premier principe actif tandis que l'enrobage contient un second principe actif selon la revendication 1, comprenant les étapes suivantes :
    - préparation du noyau comprenant soit 100% en poids, soit 60-99% en poids du premier principe actif, et, le cas échéant, au moins un agent liant, et éventuellement un agent antistatique,
    - enrobage du noyau ainsi obtenu par pulvérisation d'une solution ou d'une suspension comprenant de 60 à 99% en poids d'un second principe actif et au moins un agent liant, et éventuellement un agent antistatique,
    - séchage.
  15. Procédé selon la revendication 14, caractérisé en ce que l'étape de préparation du noyau consiste en une granulation du premier principe actif sous forme de poudre à l'aide d'un agent liant sous forme d'une solution aqueuse ou organique ou un mélange de solvant, puis séchage.
  16. Procédé selon la revendication 14, caractérisé en ce que la préparation du noyau consiste en une sélection granulométrique de micro-cristaux d'une taille comprise entre 50 µm et 400 µm, constitutif du premier principe actif.
  17. Procédé selon la revendication 14, caractérisé en ce qu'il contient une étape additionnelle d'enrobage par une couche supplémentaire fonctionnelle, dont la composition est choisie en fonction des caractéristiques souhaitées de masquage de goût et/ou de libération d'un principe actif.
  18. Procédé selon la revendication 14, caractérisé en ce que l'agent liant est choisi parmi les polymères cellulosiques, les polymères acryliques, les povidones, les co-povidones, les polyvinylalcools, l'acide alginique, l'alginate de sodium, l'amidon, l'amidon prégélatinisé, les sucroses et leurs dérivés, la gomme guar, les polyéthylèneglycols, seuls ou en mélange.
EP04703798.1A 2003-02-05 2004-01-21 Composition comprenant un melange de principes actifs, et procede pour la preparer Expired - Lifetime EP1589954B1 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
FR0301308 2003-02-05
FR0301308A FR2850576B1 (fr) 2003-02-05 2003-02-05 Composition comprenant un melange de principes actifs, et procede de preparation
US44719803P 2003-02-13 2003-02-13
US447198P 2003-02-13
PCT/EP2004/050035 WO2004069135A2 (fr) 2003-02-05 2004-01-21 Composition comprenant un melange de principes actifs, et procede pour la preparer

Publications (2)

Publication Number Publication Date
EP1589954A2 EP1589954A2 (fr) 2005-11-02
EP1589954B1 true EP1589954B1 (fr) 2016-08-31

Family

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EP04703798.1A Expired - Lifetime EP1589954B1 (fr) 2003-02-05 2004-01-21 Composition comprenant un melange de principes actifs, et procede pour la preparer

Country Status (19)

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US (2) US7846460B2 (fr)
EP (1) EP1589954B1 (fr)
JP (1) JP4791348B2 (fr)
KR (1) KR20050096963A (fr)
CN (1) CN1747723B (fr)
AU (1) AU2004210438B2 (fr)
BR (1) BRPI0407116B1 (fr)
CA (1) CA2514446C (fr)
EA (1) EA010972B1 (fr)
ES (1) ES2590807T3 (fr)
FR (1) FR2850576B1 (fr)
HK (1) HK1087015A1 (fr)
IL (1) IL169880A (fr)
IS (1) IS7998A (fr)
MX (1) MXPA05008161A (fr)
NO (1) NO341294B1 (fr)
NZ (1) NZ541886A (fr)
PL (1) PL223347B1 (fr)
WO (1) WO2004069135A2 (fr)

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JP6320297B2 (ja) * 2012-09-13 2018-05-09 ライオン株式会社 発泡性口腔用組成物、発泡性口腔用固形製剤及び発泡性口腔用製品
CA2888278A1 (fr) * 2012-10-15 2014-04-24 Isa Odidi Formulations de medicament pour administration par voie orale
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KR102229036B1 (ko) 2013-02-01 2021-03-17 더블유.알. 그레이스 앤드 캄파니-콘. 액체 기술을 위한 담체로서의 다공성 실리카 겔
WO2015023675A2 (fr) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Comprimé extrudé anti-abus à libération immédiate
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
DK3169315T3 (da) 2014-07-17 2020-08-10 Pharmaceutical Manufacturing Res Services In Væskefyldt doseringsform til forhindring af misbrug med øjeblikkelig frigivelse
AU2015336065A1 (en) 2014-10-20 2017-05-04 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
CN111990641A (zh) * 2020-05-06 2020-11-27 焦作百仑斯生物科技有限公司 一种解酒护肝片及施工方法

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Also Published As

Publication number Publication date
MXPA05008161A (es) 2005-10-05
IS7998A (is) 2005-08-25
IL169880A (en) 2013-10-31
US7846460B2 (en) 2010-12-07
BRPI0407116A (pt) 2006-01-10
AU2004210438A1 (en) 2004-08-19
NO341294B1 (no) 2017-10-02
CA2514446A1 (fr) 2004-08-19
FR2850576B1 (fr) 2007-03-23
NZ541886A (en) 2008-12-24
HK1087015A1 (en) 2006-10-06
IL169880A0 (en) 2007-07-04
KR20050096963A (ko) 2005-10-06
CN1747723B (zh) 2010-05-12
US20110081389A1 (en) 2011-04-07
JP4791348B2 (ja) 2011-10-12
CA2514446C (fr) 2012-04-10
EA010972B1 (ru) 2008-12-30
CN1747723A (zh) 2006-03-15
EP1589954A2 (fr) 2005-11-02
BRPI0407116B1 (pt) 2018-04-03
NO20053799L (no) 2005-08-11
PL376465A1 (en) 2005-12-27
US20060134422A1 (en) 2006-06-22
EA200501250A1 (ru) 2006-02-24
WO2004069135A3 (fr) 2004-10-28
PL223347B1 (pl) 2016-10-31
JP2006516597A (ja) 2006-07-06
ES2590807T3 (es) 2016-11-23
WO2004069135A2 (fr) 2004-08-19
FR2850576A1 (fr) 2004-08-06
AU2004210438B2 (en) 2007-08-16

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